Method and apparatus for minimally invasive pelvic surgery

ABSTRACT

The invention provides a driver and methods for advancing needles, cannulas, and other medical devices through the pubic bone. The driver may be used in connection with a driver frame assembly for proper positioning and stabilization of the driver, and with other devices for creating a cavity in the urethral floor and for positioning medical devices therein. The invention also provides simple connections for attaching a suture to a device within the cavity in the urethral floor or in the vagina, and also for attaching sutures to the pubic bone.

RELATED APPLICATIONS

This application claims priority from U.S. Provisional PatentApplication Ser. No. 60/038,380, filed Feb. 13, 1997.

FIELD OF THE INVENTION

The present invention relates to methods and devices for treatingurinary incontinence. More particularly, the present invention relatesto methods and devices for creating a cavity near the urethral floor,methods and devices for placement of a urethral sling or other device insuch a cavity, and methods and devices for driving bone-piercing guidesinto and through the pubic bone for use in stabilizing the urethra orpelvic floor.

BACKGROUND OF THE INVENTION

The present invention relates to the treatment of stress urinaryincontinence "SUI," and to improved methods and surgical devices for thesurgical treatment of SUI. The devices disclosed herein are additionallyuseful in a wide variety of other surgical procedures.

Genuine stress incontinence is the involuntary loss of urine due to asudden rise in intra-abdominal pressure. It has been estimated thatbetween 40% and 50% of young, healthy nulliparous women admit tooccasional mild stress incontinence; however, at least 80% of stressincontinence patients are in the perimenopausal age group and aremultiparous. Raz has suggested that the female urethral continencemechanism is dependent on the interaction of four urethral factors:urethral closing pressure, urethral length, urethrotrigonal anatomy, andurethral reception of intra-abdominal pressure. Raz, S., Modifiedbladder neck suspension for female stress incontinence, Urology, 17:82,1981.

The urethral closing pressure is predominantly a result of theinteraction of smooth and striated muscle sphincter activity, but thereis also some contribution by nonmuscular urethral factors such as thesubmucosal vascular plexus, the elastin and collagen content of theurethral tissues, and a sphincter like effect of the mucosa. There hasbeen considerable diversity of opinion regarding the anatomic structureand the innervation of the urethral sphincters, and a variety of viewshave been expressed in the literature.

Urethral length is important in the maintenance of continence. However,although it certainly interacts with other factors to contribute tocontinence, a short urethra alone will not produce incontinence.Urethral length varies considerably in normal women, and women withproven genuine stress urinary incontinence do not invariably haveurethral shortening.

Urethrotrigonal anatomy, which can be demonstrated by lateralcystourethrography, should fulfill certain criteria. The bladder baseshould lie above the level of the inferior ramus of the symphysis, andwith straining should not descend more than 1.5 cm. There should be anormal urethrotrigonal alignment with an angle normally less than 100degrees, and the urethral axis should be approximately 35 degrees fromthe vertical. In the hypermobile situation loss of all of the normalanatomic features may occur, a radiologic finding that correlates withthe clinical finding of cystourethrocele. However, clinical experiencehas shown that the coexistence of cystourethrocele and incontinence doesnot predict that the incontinence is of a genuine stress variety.

The transmission of intra-abdominal pressure to the intra-abdominalportion of the proximal urethra is also reported to be important in themaintenance of continence. This is a passive phenomenon, and is theresult of the normal anatomic configuration just described. Wheneverthere is a rise in intra-abdominal pressure during such stresses ascoughing or straining, the pressure is transmitted not only to thebladder but also to the proximal urethra, with resultant increase in theclosing pressure, and prevention of leakage. If the urethral axis isaltered, rotational descent will drop the proximal urethra and bladderbase from its intra-abdominal location, and will obviously impair suchpressure transmission.

A wide variety of operations have been used to correct this condition,generally involving the principles of elevating the bladder neckanteriorly and/or elongating and narrowing the proximal urethra. Two ofthe most popular operations today for stress incontinence are theMarshall-Marchetti-Krantz and Birch vesicourethropexies. TheMarshall-Marchetti-Krantz technique has at least an eighty-five percentsuccess rate, against which other operative success rates must bemeasured. Recently, the Pereyra operation and its modifications haveenjoyed some popularity, but less than basic techniques.

Notwithstanding the foregoing, however, there remains a need for animproved treatment for SUI. Preferably, the treatment is as noninvasiveas possible under the circumstances, and will eliminate or minimizehospitalization and the use of general anesthetics. In addition, thereremains a need for improved medical instrumentation such as tissuecavity dilators, incision guides, bone-piercing guide drivers, andquick-connect slings and suture-securing devices for use in connectionwith SUI treatment and other medical procedures. U.S. Pat. No.5,611,515, issued Mar. 18, 1997 to Benderev et al., introducespioneering minimally invasive percutaneous and transvaginal bladder neckstabilization approaches. The percutaneous approach of Benderev et al.involves stabilizing the bladder neck using a bone anchor which ispercutaneously introduced from the abdominal side of the patient. Thetransvaginal approach of Benderev et al. involves stabilizing thebladder neck using a staple or bone anchor which is transvaginallyplaced into the pubic bone. The methods and devices of the presentinvention may be used in several urethral or bladder neck stabilizationprocedures that are less invasive than many of those currentlyavailable.

SUMMARY OF THE INVENTION

It is an objective of this invention to provide a means and method forrelatively sterile placement of urethral slings. It is a furtherobjective of this invention to provide an apparatus for straight linepositioning for bone piercing, so as to achieve proper placement ofurethral slings and to minimize difficulty in aligning a bone-piercingapparatus with the ultimate target in a tissue cavity. Another objectiveis to provide apparatus and a method for reconstructing and stabilizingthe urethral or pelvic floor by affixing devices placed to support theurethral or pelvic floor to a fixed reference tissue such as a bone. Afurther objective is to provide improvements over current techniquesthat require drilling holes in a bone, and the placement of bone anchorstherein.

This invention has the additional objective of providing rapid andsimple surgical connections for connecting a suture to a medical deviceinside a tissue cavity or other structure in the body that may be inneed of stabilization. This invention also seeks to provide alternativesto transvaginal methods of urethral and pelvic floor reconstruction andstabilization, to minimize the risk of infection, and to enable surgeonsto approach the urethral or pelvic floor from different locations.Finally, it is a further objective to provide minimally invasive meansand methods of securing a target tissue to an immoveable referencetissue, such as the pubic bone. One of more of these objectives issatisfied by various embodiments of the invention.

The invention provides a dilator for creating a cavity in tissue. Thedilator has two functional portions: an insertion spreader and handles.The insertion spreader includes of two facing guides that may besemi-cylindrical. The spreader has open and closed positions. In theclosed position the guides are close together and the dilator may havethe appearance of a split tube or cylinder, while in the open positionthe guides are separated. In both positions the guides remainessentially parallel to each other.

The insertion spreader may be attached to the handles for manipulationof the guides. The handles can be joined together with a pivot, so thatpivoting the handles translates to a movement of the guides eithertoward or away from one another. The dilator may also have a ratchetinglock for maintaining the insertion spreader in a fixed position. Thepenetrating ends of the guides also may be sharpened to facilitatepenetrating the target tissue.

The dilator aspect of the invention also provides a method of creating atissue cavity by using the dilator. With the insertion spreader in theclosed position the spreader is advanced into the target tissue. Whenthe spreader reaches the desired depth the handles are moved to separatethe guides. The separation of the guides causes a tearing of the tissue,creating a cavity therein. This method also may be employed by firstadvancing a needle partially into the tissue to create an insertionpath. The guides of the spreader are positioned about the protrudingpart of the needle and inserted into the tissue along the same pathcreated by the needle.

This method for spreading tissue with the dilator of the invention maybe used to create a cavity in the vaginal hiatus. The term "vaginalhiatus" refers to the tissue between the urethra and the vagina. Thisterm may apply to the exterior surface between the distal urethra andthe vaginal orifice as well as to the deeper tissue between the urethraand the upper vaginal wall. In some cases spreading may be facilitatedby performing an episiotomy of the skin of the vaginal hiatus. Themethod of this aspect of the invention also may be performedtransvaginally to create a cavity, for example in the vaginal wall.Whatever the tissue, the method may be preceded with a fluid-dissectionof the target tissue, wherein a solution is injected into the tissue tocreate a fluid bolus. The fluid bolus forms a pocket in the tissue, andthe dilator is used to create an opening connecting the outer surface tothe pocket.

The invention also provides an insert card for advancing a medicaldevice, for example a urethral sling, into a tissue cavity. One end ofthe card holds the sling to be used for stabilizing tissue or internalstructures of the urethral or pelvic floor. The other end of the card isfashioned to permit a physician to grasp and manipulate the card, or toalign or connect the card with other external devices, such as thosedisclosed herein. The sides of the card may be adapted for use with thedilator mentioned above. Thus the card can be used to enhance both thesterility and the positional precision in a sling-placement procedure.

The card and the dilator may thus be used in a method of advancing asling into a tissue cavity. The tissue cavity is created by the dilatoras described above, and the spreader is locked in the open position. Asling is placed in the proper position on the card, and the card ispositioned so that its lateral edges align with and slide into thespreader guides. The spreader guides provide a track for the insertionof the card to the desired depth within the cavity. This method of slingplacement may be used in procedures employing a variety of techniquesfor securing the sling, including techniques adapted for slings that areto be secured with sutures, quick connect devices, bone anchors,staples, and the like.

Also provided in this invention is an incision guide for creating acavity between the urethra and the vagina. The incision guide has acatheter that is inserted into the urethra. This catheter expands andstraightens the urethra, essentially immobilizing the urethra in aneasily identified position. Also part of the incision guide is a cutterthat slides along the catheter and makes an incision into the vaginalhiatus that is a fixed distance from, and therefore parallel to, theurethra. The catheter may display graduation marks or other indicia toenable a surgeon to determine the position of the catheter or the cutterrelative to the bladder neck.

The incision guide of the invention may also have a stop, such as ablock or a ring, that locks in place on the catheter. The stop abuts thecutter and prevents insertion of the cutter beyond the desired depth ofincision.

The cutter portion of the incision guide may be a needle, a blade, abipolar knife, or other incision device adapted for slidably mounting tothe rigid catheter. One example of such an adapted incision device isthe dilator of the invention as described above.

The incision guide aspect of the present invention provides a method ofcreating a cavity in the vaginal hiatus. The method includes the stepsof inserting the catheter into the urethra, determining the position ofthe bladder neck by using the catheter, and inserting the attachedcutter into the vaginal hiatus. The catheter allows straight-linetracking for the cutter and indicates the depth of incision, thusavoiding injury to the bladder.

This method of creating a cavity in the vaginal hiatus may be used inconcert with the method of placing a sling in a cavity by use of thecard, as discussed above. The card supporting the sling may advance intothe cavity having its edges in contact with the hiatal tissue along thesides of the cavity. Alternatively the dilator of the invention also maybe used to serve as a guide for the card, after the cavity is made usingthe incision guide of the invention. When the card reaches the intendeddepth in the cavity, the sling is in proper position for fastening inplace.

An additional aspect of the present invention provides a driver fordriving a guide into or through the pubic bone. The driver has two jawsand a slide bar. The first jaw has a distal end that inserts into atissue cavity and a proximal end that attaches to the slide bar. Thesecond jaw slides along the slide bar toward the first jaw. The secondjaw has a bone-piercing guide attached to it such that the guide movestoward the first jaw when the second jaw is advanced along the slidebar. The guide connected to the driver may be a cannula, a needle, or alike device adapted for driving through bone.

The driver provides a method of driving a guide through the pubic bone.The steps include: inserting the first jaw of the driver into a tissuecavity, locating the pubic bone, positioning the driver to align thepubic bone between the first jaw and the second jaw, and advancing thesecond jaw toward the first jaw to drive the guide through the pubicbone.

The invention further provides a method for passing a device through thepubic bone. The guide is driven through the pubic bone as outlinedabove. The guide is next retracted, leaving a path through the bone, andthe device is passed through the pubic bone along the path made by theguide. The device passed by this method may be a suture, a suturepasser, a quick-connect fastening device, and the like.

In an additional method of this aspect of the invention, the driver ofthe invention is used to advance a cannula through the pubic bone. Thelumen of the cannula constitutes a channel through the pubic bone. Adevice may then be passed through the bone within the lumen of thecannula. Devices that may be passed by this method include a suture, asuture passer, a quick-connect fastening device, and the like.

A further method of pelvic surgery provided by the invention includesthe following steps. A cannula is driven through the pubic bone with thedriver of the invention. The cannula is further driven into the tissuecavity in which the first jaw of the driver is positioned. The first endof a suture is passed through the cannula and secured to a structurewithin the cavity. The second end of the suture is secured to the pubicbone, thereby stabilizing tissue adjacent to the cavity. According tothis method, the cannula may be removed from the bone before either endof the suture is secured, or the suture within the tissue cavity may besecured before withdrawal of the cannula. The suture within the tissuecavity may be secured by stitching the suture through a tissue mass ofthe cavity, or by attaching the suture to a structure introduced intothe cavity for stabilizing the tissue of the cavity, such as a suturebutton.

The invention also provides a method of pelvic surgery wherein a cannulais driven through the pubic bone and into the tissue cavity as describedabove, and a suture is passed through the cannula and into the cavity.The suture is passed through a structure therein to stabilize the tissueadjacent to the cavity, then the suture is passed back out along thesame path through the bone, and both ends of the suture are secured tothe pubic bone.

Yet another method of the invention involves driving a cannula throughthe pubic bone and into a tissue cavity in a first location to make afirst path. The suture is then advanced into the cavity along the firstpath. The suture is passed through a structure of the cavity tostabilize the tissue adjacent to the cavity. The cannula is then driventhrough the bone and into the cavity along a second path, and the sutureis withdrawn from the cavity along the second path. Both ends of thesuture are then secured to the pubic bone.

The foregoing methods focus on the path of the suture: the suture may beadvanced one-way into the cavity and affixed there, or the suture may beadvanced and withdrawn from the cavity along the same path through thebone, or the suture may be advanced and withdrawn along two separatepaths through the bone. Regardless which method is used, the tissuecavity of the method may be the vagina. Alternatively, the cavity may bea hiatal cavity made according to a method of the dilator or incisionguide aspects of the present invention. Further, the tissue cavity ofthe method may be a transvaginally created pocket into the plane of thevaginal hiatus. Also regardless which method is used, the method mayadvantageously be performed on the left side of the cavity and on theright side of the same cavity by piercing the pubic bone on both sideslateral to the pubic symphysis. The method may also include a step oftensioning the suture to elevate or otherwise stabilize the tissue mass.

Further provided is a method of stabilizing a urethral sling relative tothe pubic bone. This is done by creating a tissue cavity and creating apath through the pubic bone by driving a guide through the bone. Then aurethral sling is placed into the cavity. A suture is passed through thepubic bone along the path, and is attached to the tissue mass. Thesuture is then secured to the pubic bone to stabilize the tissue.

Another aspect of the invention provides a driver frame assembly forpositioning and stabilizing a bone-piercing guide driver relative to thepatient. The driver frame assembly includes an upper clamp and a lowerclamp, as well as a catheter, a cavity tongue, and the driver. The upperclamp has a head portion, a descending arm, and a base portion. The headportion has a compression foot for compressing the patient's abdominalsurface against the pubic bone. Stabilizing pins extend downward fromthe compression foot and penetrate the abdominal surface adjacent to thesuperior surface of the pubic bone. The base portion of the upper frameattaches to the catheter and the tongue. The catheter is used to expandand straighten the urethra; the tongue inserts into the cavity,providing counterpressure to oppose the pressure of the compressionfoot. The lower clamp has a buttock plate for insertion beneath thepatient, so that the patient's weight rests on the plate to secure theframe assembly relative to the patient. The lower clamp also has anascending arm that connects with the base portion of the upper clamp.Finally, at least one driver is attached to the descending arm of theupper clamp. There may be more than one driver mounted to the frameassembly, or there may be one driver that drives two bone-piercingguides, which may be displaced to the left and right of center relativeto the patient.

This aspect of the invention provides a method for stabilizing pelvictissue by relatively non-invasive pelvic surgery. The foregoing frameassembly is installed on the patient. The bone-piercing guide ispositioned and is driven through the bone and into the cavity. Astabilizing device is passed along the path through the bone created bythe guide and secured in the cavity, thus stabilizing the targetedtissue of or adjacent to the cavity. This method may employ two or moreguides, or one guide in various positions, to create more than one paththrough the pubic bone. The path created may be directly through thebone, after removal of the guide, or may be through the guide itself, ifthe guide is a cannula.

The stabilizing device thus passed through the bone may be a suture, asuture passer, a quick connect device, and the like. The cavity may bethe vagina, a cavity of the vaginal hiatus, or a cavity made by entrythrough the vaginal wall. The method of stabilization may be a suturestitching of the cavity tissue or the placement of a quick connectdevice to a sling or suture button. The tissue stabilization is achievedby securing the suture to the bone with a quick-connect bone suturefastener. A sling, suture button, or like device that attaches to thesuture or quick connect may be positioned in the tissue cavity by usingthe card discussed above in cooperation with the frame. The tongue ofthe frame may be adapted to cooperate with the card much like thedilator of the invention, such that the proper placement of the tongueas part of frame installation assures proper positioning of the deviceto be carried on the card for binding the device to a suture or a quickconnect device. This card may be advanced into position in a cavity ofthe vaginal hiatus, the vagina, or a cavity made in the vaginal wall.

Another aspect of the invention provides a system for attaching aurethral sling to a suture. The system includes a urethral sling and aconnector. Part of the sling is a ring member. The ring member has acentral opening that cooperates with the sling to allow unidirectionalpassage of the connector through the opening, and to prevent retrogradepassage of the connector through the opening. The connector and ringmember may have a variety of configurations. One such configurationprovides a ring member having several flanges and a substantiallyconical connector with a shoulder that contacts the flanges, preventingwithdrawal of the connector from the ring member. Another configurationprovides a connector having an elongate axial segment and a leadingsegment that is flexibly perpendicular to the axial segment. This "T"connector may cooperate with a ring member that is simply an opening inthe urethral sling. The connectors of any configuration may be aattached to a suture.

This aspect of the invention provides a method for securing a sling forurethral and pelvic floor reconstruction. A sling having a suitable ringmember is placed in position in a tissue cavity. A suture with asuitable connector is passed through the pubic bone, and the connectoris advanced through the ring member of the sling. The suture is thenfastened to the pubic bone, thus securing the sling in the cavity. Thecavity may be the vagina, a cavity of the vaginal hiatus, or a cavity inthe vaginal wall.

A closely related aspect of the invention provides a system forattaching a securing device to a suture. The system includes a securingdevice with a ring member, and a connector that attaches to a suture.The ring member and the connector cooperate as described above. Thesecuring device may be a suture button, a staple, or a quick connect.

The method provided in this aspect of the invention is a method forsecuring a target tissue to the pubic bone. The securing device with aring member is placed within or adjacent to the target tissue. A suturewith a suitable connector is passed through the pubic bone, and theconnector is advanced through the ring member of the securing device.The suture is fastened to the pubic bone, thus securing the targettissue to the bone.

Also part of the present invention is a bone eyelet having a sleeve andat least one crosspiece. The sleeve has an outer surface and an innersurface. The outer surface is adapted for inserting into a bone, and thecrosspiece is attached to the inner surface to transect the sleeve,providing a plurality of channels in the sleeve. The crosspiece may be aplane or a rod. Alternatively, the crosspiece may be created by apiercing or crimping of the sleeve. The sleeve may have an externalfriction surface for contacting with the bone. It may have a flange rimfor suspending the sleeve at the surface of the bone. The sleeve mayalso have a conical shape to facilitate advancing the sleeve into andcontacting it with the bone.

The invention provides a method for securing a suture to a bone. Thebone is pierced and a suture is passed through the bone. Suture ends arepassed through at least two channels in the bone eyelet and the boneeyelet is placed in the opening in the bone. The suture ends are thentied, thus securing the suture to the bone. The bone may be pierced witha drill or with a driver as described above. The suture may be connecteddirectly to a tissue or to a medical device, such as a sling, a quickconnect device, a suture button, a staple, an implant, or to itself.Appropriate tension on the suture may be provided, for example with useof a suture tensioner.

The invention also provides a quick-connect bone suture fastener forfastening suture to a bone. The suture fastener consists of a sleeve anda sleeve plug. The sleeve has at least two openings through which suturemay pass. The sleeve is adapted for inserting into a bone, and has asurface for frictionally contacting the sleeve plug, which functions toocclude at least one of the openings. The friction surface of the sleevemay be threaded for contacting with a threaded sleeve plug; the frictionsurface also may be a plurality of flanges that overlie the top of thesleeve plug after the plug is inserted into the sleeve. There also maybe a friction surface on the outside of the sleeve for contacting withthe bone. The sleeve may have a flange rim for suspending the sleeve atthe surface of the bone. The sleeve may also have a conical shape tofacilitate advancing it into and contacting it with the bone.

This aspect of the invention provides a method for quick connection of asuture to a bone. A bone is pierced and a suture is passed through thebone and through the sleeve. The sleeve is then pressed into the openingin the bone. The sleeve plug is then inserted into the sleeve, and thesuture is secured. The bone may be pierced by drilling or by driving aguide through the bone. The suture may be attached to tissue or to adevice, as described above. The suture may be tensioned with a suturetensioner prior to placement of the sleeve plug.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the urethra, the vaginal wall and the vagina in transversecross section.

FIG. 2a represents the insertion of a needle into the vaginal hiatus.

FIG. 2b illustrates the insertion of a dilator into the vaginal hiatusover the needle of FIG. 2a.

FIG. 2c depicts the withdrawal of the needle of FIG. 2a and furtherinsertion of the dilator of FIG. 2b.

FIG. 2d represents the dilator of FIG. 2c in the open position.

FIG. 2e illustrates the alignment of the insert card with the guides ofthe dilator of FIG. 2d.

FIG. 2f shows the insertion of the insert card between the guides of thedilator of FIG. 2d.

FIG. 2g shows the insert card in position in the hiatus after withdrawalof the dilator.

FIG. 3 is a partial longitudinal cross section of the vagina, urethra,and bladder showing a rigid catheter in place in the urethra.

FIG. 4 is a cross section as in FIG. 3, and shows a rigid catheter withthe stop attached.

FIG. 5 is a cross section as in FIG. 3, and shows an incision guideassembly with a catheter, stop, and cutter in place.

FIG. 6a is a transverse cross section taken along the line 6--6 in FIG.5 and illustrates the hiatal region of the patient with the catheter inplace and the cutter as a needle.

FIG. 6b is a transverse cross section as in FIG. 6a and shows the hiatalregion with the catheter in place and the cutter as a blade.

FIG. 7 is a cross section view of the pelvis as in FIG. 3 with thedriver positioned above the pubic bone.

FIG. 8 is a cross section including a driver as in FIG. 7, depicting thepassage of the bone-piercing guide through the pubic bone lateral to theurethra and into the vagina.

FIG. 9a is a transverse cross section taken along the line 9--9 in FIG.8, showing the distal end of the first jaw of the driver in position inthe vagina, with cannulas forming a passage through the pubic bone andinto the vagina.

FIG. 9b is a cross section as in FIG. 9a that illustrates passagethrough the cannulas of a suture and connecting device.

FIG. 10a is a cross section as in FIG. 9a, showing the pubic bone, theurethra, the hiatal region and the vagina, with sutures attached on theright and left sides of the upper vaginal wall.

FIG. 10b is a cross section as in FIG. 10a, showing elevation of theurethra resulting from tensioning of the sutures.

FIG. 11 is a cross section view of the pelvis as in FIG. 3 with theupper clamp of the driver frame assembly in place, articulating with therigid catheter and the tongue.

FIG. 12a is a cross section taken along the line 12--12 in FIG. 11, andillustrates the hiatal region depicting a flat insertion tongue.

FIG. 12b is a cross section taken along the line 12--12 in FIG. 11, anddepicts a concave insertion tongue in a hiatal cavity.

FIG. 12c is a cross section taken along the line 12--12 in FIG. 11, anddepicts a concave insertion tongue in a hiatal cavity.

FIG. 13 is a cross section view of the pelvis as in FIG. 3 showing thecomplete driver frame assembly in place.

FIG. 14 is a cross section view taken along the line 14--14 in FIG. 13,showing left and right displacement of the bone-piercing guides mountedon the driver.

FIG. 15 is a cross section as in FIG. 3, and depicts the driver frameassembly with the bone-piercing guides penetrating to the hiatal cavity.

FIG. 16 illustrates the pubic bone with the guides passing through thebone left and right of the pubic symphysis.

FIG. 17 is a cross section view of the pelvis as in FIG. 3 and thedriver frame, with the tongue supporting an insert card and a sling inposition.

FIG. 18 is a cross section taken along the line 19--19 in FIG. 17, andshows the position of the rigid catheter inside the urethra, the tongue,the insert card, and the sling.

FIG. 19 is a cross section as in FIG. 17 with the driver frame in place,and shows the driver frame with the driver removed and a cannula inposition.

FIG. 20 corresponds to FIG. 19, but shows the driver frame with thecannula in place and a suture with quick-connect device passing throughthe cannula.

FIG. 21 is a detail view of the area described by the curved arrows inFIG. 20, and shows detail of the quick-connect device passing throughthe cannula toward the sling.

FIG. 22 corresponds to FIG. 21, and provides detail of the quick-connectdevice articulating with the ring member of the sling.

FIG. 23 is a cross section taken along the line 23--23 in FIG. 22, andshows the position of the rigid catheter, left and right side cannulas,and a quick-connect device in the left cannula articulated with the ringmember of the sling.

FIG. 24a illustrates in cross section the position of the concaveinsertion tongue with contact pins relative to the urethra, the pubicbone, and the compression foot of the driver frame assembly, prior toapplication of counterpressure on the pubic bone by the concave tongue.

FIG. 24b corresponds to FIG. 24a and shows the concave tongue andcontact pins providing counterpressure against the inferior posteriorface of the pubic bone.

FIG. 25 is a view of the insertion tongue from the direction 25--25 ofFIG. 24a, and provides detail of the elevated edge of the concaveinsertion tongue, showing the position of the contact pins and thepassage gap.

FIG. 26a corresponds to FIG. 24b, and shows the compression foot withbone driver guides passing through the pubic bone and passage gap of thetongue.

FIG. 26b corresponds to FIG. 26a, and shows the withdrawal of the guidesand the position of the sutures.

FIG. 27a corresponds to FIG. 26b, and shows the orientation of thesutures, the tongue, and the hiatal cavity before tensioning of thesutures.

FIG. 27b corresponds to FIG. 27a, and shows the elevation of the hiatalcavity and the urethra after tensioning of the sutures.

FIG. 28 is a cross section view as in FIG. 3 showing a sling with thering member of a quick-connect device in place.

FIG. 29 is a plan view of a sling with the ring member of aquick-connect device in place.

FIG. 30 is a cross section view taken along the line 30--30 in FIG. 29,showing the sling with the quick-connect ring member in place.

FIG. 31 is a plan view showing the bone eyelet in position in a bonewith suture on either side of the crosspiece.

FIG. 32 is a cross section taken along the line 32--32 in FIG. 31, anddepicts the bone eyelet with a planar crosspiece in position in thepubic bone and connected by suture to an arrowhead configuration of thequick-connect device articulated with the ring member of the sling.

FIG. 33 corresponds to FIG. 32a, but shows a bone eyelet with a rodcrosspiece in place in the pubic bone connected via suture to aT-configuration of the quick-connect device.

FIG. 34 is a perspective view of the T-configuration of thequick-connect device.

FIG. 35 is a side elevation that depicts the passage of theT-configuration of the quick-connect device through a cannula toward thering member of a sling.

FIG. 36 is a perspective view of a bone suture fastener and a sleeveplug oriented above the pubic bone.

FIG. 37a is a cross-section taken along the line 37--37 in FIG. 36 andillustrates suture passing through the sleeve with the sleeve plug inplace.

FIG. 37b is a cross section view similar to FIG. 37a showing thezipper-lock configuration of the bone suture fastener with the sleeveplug in place.

FIG. 38 is a cross section view similar to FIG. 37a showing the threadedconfiguration of the bone suture fastener with the sleeve plug in place.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The treatment of incontinence for intrinsic sphincter deficiency (ISD)can often be corrected surgically with the placement of a sling. Thissling may consist of a wide variety of well known biocompatiblematerials: bovine pericardium, autograft, synthetics, cadaveric tissue,collagen/synthetic blends and the like. The sling also may be placedthrough a variety of surgical procedures. Slings suitable for use inurethral or bladder neck stabilization or suspension procedures andmethods for implanting them are disclosed in the copending U.S. PatentApplication entitled "Stabilization Sling for Use in Minimally InvasivePelvic Surgery" U.S. patent application Ser. No. 09/023,398, filedsimultaneously herewith, and the identically titled U.S. ProvisionalPatent Application Ser. No. 60/038,379, filed Feb. 13, 1997, thedisclosures of which are incorporated herein by reference. The extent ofsurgical intervention is a surgeon's preference, but all presentsurgical interventions require a vaginal incision. The presence ofmicroorganisms is high in the vagina; in procedures utilizing slings ofnon-autologous material, a high rate of infection has been reported. Theprocedure described herein approaches sling placement in a differentmanner from that requiring a vaginal incision. The vaginal hiatus isapproached just under the distal urethra and a cavity is dilated withinthe tissue parallel to the urethra and upper vaginal wall. This deviceand resultant pocket provide access for placement of the sling in thetreatment of ISD and urethral hypermobility. The dilator also may beused in an approach from within the vagina to create a pocket in thedesired location approaching the bladder neck.

Turning now to the drawings, FIG. 1 shows the urethra and the vagina 4with the vaginal wall 8 in between. The dotted line in FIG. 1 representsan incision site in the vaginal hiatus 2. The vaginal hiatus 2 is theexternal tissue between the urethra and the vagina 4, as well as thetissue deep to that external tissue. The vaginal wall 8 is intended torefer to all interior surfaces of the vagina 4.

The series of FIGS. from 2a to 2g demonstrates a sequence having to dowith one aspect of the present invention, referred to herein as thedilator 10. The dilator 10 consists of two distinct functional units,the insertion spreader 12 and the handle 18. The insertion spreader 12can have the appearance of a split tube, and each half of the insertionspreader 12, or each half of the split tube, can be an elongatedsemi-cylindrical spreader guide 14. The invention contemplates spreaderguides 14 shaped other than semi-cylindrically, such as spreader guides14 whose cross section when joined would describe a square, a hexagon,and the like, depending on the application for which it is used, anddepending on the configuration of the card, to be discussed below.

The spreader 12 has an open position in which the spreader guides 14 areseparated from each other, as in FIG. 2d, as well as a closed positionin which the spreader guides 14 are closely aligned, substantiallyforming a cylinder, as in FIG. 2c. The preferred separation of thespreader guides 14 in the open position is approximately 2.5 to 4 cm.

The spreader guides 14 are substantially parallel to each other whetherthe spreader 12 is in the open or closed position, or is moving from oneposition to another. The spreader guides 14 have a distal end 15 and aproximal end 16, the distal end 15 being for insertion into the tissue9, and the proximal end 16 being for attachment to the handles 18. In apreferred embodiment of this invention, the spreader guides 14 aresharpened at the distal end 15, to facilitate entry into a tissue 9 andpassage therethrough. The distal ends 15 of the spreader guides 14 alsomay be shaped to cooperate with a needle 24, which may be inserted firstinto the tissue 9 (see FIG. 2a) before insertion of the spreader guides14, to provide a path for the spreader guides 14 to follow into thetissue 9 as they are inserted over the needle 24 (FIG. 2b).

The handles 18 of the dilator 10 have first 19 and second 21 ends. Thefirst end 19 of each handle 18 is connected to the proximal end 16 ofeach guide. The second end 21 of each handle 18 is adapted for aphysician to grasp and manipulate the handles 18. The handles 18 arejoined at a pivot 20 and may be moved about the pivot 20 relative to oneanother, in such a way that movement of the handles 18 translates todisplacement of the spreader guides 14 relative to one another. In apreferred embodiment of the invention, a ratcheting lock 22 is also partof the handles 18, and provides a mechanism for the handles 18 to belocked into a particular position, thus also locking the spreader 12 ina particular position.

This aspect of the invention provides a method for creating a cavity ina tissue 9. The needle 24 is optionally first inserted into the tissue 9as in FIG. 2a. The spreader guides 14 of the spreader 12 are placed in aclosed position and are inserted into the tissue 9 over the needle 24(FIG. 2b) or directly into the tissue 9. The needle 24, is used, is thenwithdrawn (FIG. 2c). When the spreader guides 14 are inserted to thedesired depth, the handles 18 of the dilator 10 are moved together, asshown in FIG. 2d. This causes a separation of the spreader guides 14until the dilator 10 is in the open position. The movement of thespreader guides 14 away from each other toward the open position createsa cavity in the tissue 9.

In a preferred embodiment of the method of this invention, the tissue 9is the vaginal hiatus 2. In some cases, the practice of this method maybe facilitated with the additional step of preforming an episiotomy onthe skin of the vaginal hiatus 2. In an alternative embodiment, thismethod may be practiced on a tissue 9 of the vaginal wall 8, for examplethe upper vaginal wall, to create a cavity between the vagina 4 and theurethra. Also contemplated in this invention is the practice of thismethod in any tissue 9 wherein it may be advantageous to simultaneouslycreate a cavity and provide guide tracks for placement of a medicaldevice within the cavity.

An additional preferred embodiment of the method of the invention has asa first step the insertion of a needle 24 into the target tissue 9, suchas the vaginal hiatus 2 or vaginal wall 8, as in FIG. 2a. The needle 24may be calibrated or otherwise marked to indicate the depth of itsinsertion, to allow a physician to accurately determine the proximity ofthe tip of the needle 24 to an internal structure, such as the bladderneck 47. In addition to a determination of the depth of penetration, theneedle 24 may also provide a path for simplified insertion of thespreader 12 of the invention.

Using an embodiment of the dilator 10 wherein the distal ends 15 of theguides 14 are adapted for cooperating with a needle 24, the spreader 12is moved to the open position, and the spreader 12 spreader guides 14are placed near the needle 24, then the spreader 12 is moved to theclosed position. In the closed position the spreader guides 14, at leastat their distal ends 15, substantially conform to the shape of theneedle 24 and may follow its path into the tissue 9, as in FIG. 2b. Thespreader guide 14 is then inserted to the desired depth, at which pointthe needle 24 may be withdrawn, as in FIG. 2c. Then, as before, thehandles 18 are moved closer together, thus moving the spreader guides 14away from each other to the open position (FIG. 2d). The ratcheting lock22 portion of the handles 18 holds the handles 18 together and thespreader guides 14 apart. Movement of the spreader guides 14 to the openposition creates the cavity desired for insertion of a medical device,or for performing a desired surgical procedure.

As an alternative embodiment of this method, an additional step may bepreformed to facilitate creation of the cavity. In this embodiment, thetarget tissue 9 is fluid-dissected by injecting a solution into thetissue 9 prior to advancing the insertion spreader 12 into the tissue 9.This additional step of hydro-dissection may be preformed using avariety of physiologically suitable buffers or solutions. Thisadditional step provides an advantage in some cases, becausehydro-dissection may be tissue-selective with respect to the vaginalhiatus 2 and the urethra. That is, hydro-dissection may tend topreferentially dissect hiatal tissue without impinging upon urethral orbladder tissue. Accordingly, a first step of hydro-dissection thatcreates a saline bolus, may predissect the tissue without affecting theintegrity of the urethra. The subsequent step of passing the insertionspreader 12 into the tissue is therefore simplified, and the movement ofthe spreader guides 14 into the open position is also simplified,because a substantial portion of the cavity is already created by theprocess of hydro-dissection.

In one method of hydro-dissection and subsequent cavity opening with useof the dilator 10, a needle is inserted into the upper vaginal wall 8and the saline solution is delivered into the deep tissue of the vaginalhiatus 2. The deep tissue of the vaginal hiatus 2 is thereby dissectedby the injected solution. Subsequent insertion of the spreader 12through the external skin of the vaginal hiatus 2 provides a route ofentry that is less susceptible of infection than may be the case where atissue cavity is created entirely transvaginally. Because the interiorof the vagina 4 harbors more microorganisms than the surface of thevaginal hiatus 2, and is also much more difficult to surface sterilize,the exterior vaginal hiatus 2 may often be the preferred route of entryfor creating a tissue cavity for urethral and pelvic floorreconstruction. However, certain circumstances may dictate creation of atissue cavity transvaginally; the dilator 10 of the invention and themethods of its use are fully adaptable to creation of a cavitytransvaginally. Thus, the present invention provides a surgeon with aconvenient means of opening a tissue cavity and with alternative avenuesof entry to the tissue cavity. Additional devices and methods fortransvaginal urethral or pelvic floor reconstruction and urethral orbladder neck stabilization or suspension, suitable for use in connectionwith the present invention, are disclosed in the copending U.S. patentapplication Ser. No. 08/744,439 entitled "Transvaginal AnchorImplantation Device," filed on Nov. 8, 1996, the disclosure of which isincorporated herein by reference.

Another aspect of the present invention is a card 30 for advancing amedical device into a tissue cavity as shown in FIG. 2e. The card 30 haslateral edges 32, a distal portion 34, and a proximal portion 38. A partof the proximal portion 38, the articulation opening 40, may be adaptedfor articulation with additional devices that may be useful inpositioning or stabilizing the card 30 in certain methods of use. Thedistal portion 34 of the card 30 is adapted for carrying a medicaldevice into a tissue cavity. In one embodiment of the invention themedical device is a urethral sling 42 in one embodiment the sling 42includes one or more ring members 44. The card 30 enables sling 42manipulation without touching the sling 42. This reduces contamination,and establishes the sling 42 position within the body and relative toother devices that may be used in positioning and securing the sling 42.The lateral edges 32 of the insert card 30 may be specially adapted toarticulate with spreader guides 14 that provide a path into the tissuecavity, such as the spreader guides 14 of dilator 10. The distal portion34 of the card 30 is inserted into the cavity by aligning it with theproximal ends 16 of the spreader guides 14. Once the card 30 is thusaligned, the edges 32 of the card 30 easily slide along thesemi-cylindrical spreader guides 14 into the cavity until reaching theproper depth in the cavity.

The card 30 and dilator 10 of the invention thus may be used in a methodfor inserting a medical device into a tissue cavity. In a preferredembodiment of this invention, the medical device is a sling 42. Othermedical devices that may be positioned with use of the card 30 includepharmaceutical implants, therapeutic devices, closures, staples andclips. In the preferred method, a urethral sling 42 is placed at thedistal region of the insert card 30. A cavity is formed in a targettissue 9 as described above. Briefly, the spreader 12 is placed in aclosed position and the spreader guides 14 are positioned against thesurface of the target tissue 9. The spreader 12 is inserted into thetarget tissue 9 and is then moved to the open position by moving thehandles 18 of the dilator 10 together. The spreader 12 is held in theopen position by the ratcheting lock 22. With the sling 42 on the card30 and the cavity opened, the card edges 32 are aligned with thesemi-cylindrical spreader guides 14 of the dilator 10 and the card 30 isinserted into the cavity until it reaches the desired depth. The card 30is manipulated by its proximal portion 38, and may be manipulated bymeans of an accessory tool contacting the card 30 at the articulationopening 40.

There are several advantages to this method of the invention. Oneadvantage is that the medical device can be placed without excessivecontact between the device and the patient. Excessive contact betweenthe surgeon and the device also may be avoided, which allows a reductionin handling and a reduced likelihood of contamination. This factminimizes the risk of infection in the placement of the device. Anotheradvantage is that the card 30 provides support for the device insubsequent steps of attaching the device in place inside the tissuecavity. A further advantage is that the spreader guides 14 providetracks along which the card 30 may enter, minimizing difficulties andvariability in the location of the sling 42 in the desired position.

This method is applicable to cavities made in the vaginal hiatus 2 aswell as in the vaginal wall 8, specifically in the upper vaginal wall.Other uses for this method, involving the placement of a medical devicesupported on a card 30 with the assistance of the dilator 10 of theinvention, will be evident to those of skill in the art.

FIGS. 2e, 2f and 2g show the steps of the method after the cavity iscreated. In FIG. 2e the card 30 holding the sling 42 is aligned with thespreader guides 14 of the dilator 10. In FIG. 2f the card 30 is insertedinto the cavity by sliding the sides of the card 30 along thesemicircular tracks provided by the spreader guides 14 of the dilator10. FIG. 2g shows the card 30 in position in the tissue cavity afterremoval of the dilator 10. As can been seen in FIG. 2g the proximalportion 38 of the card 30 and the articulation opening 40 remain outsidethe cavity for continuing or subsequent interaction with accessorytools, such as those which are disclosed below in a discussion of otheraspects of this invention.

The placement of the sling 42 or some other medical device by the methodof this aspect of the invention preferably precedes the securing of sucha medical device inside the tissue cavity. The invention contemplatessecuring the sling 42 or other medical device in several different ways.In one embodiment the sling 42 may be placed in the cavity to be suturedtherein by a suture 88 entering the cavity from the upper vaginal wall8. In another embodiment the sling 42 may be stapled or anchored intoplace subsequent to its positioning with the use of the card 30.Suturing of the sling 42 into position also may be accomplishedpercutaneously, or with the suture being advanced from above or throughthe bone. Additional devices and methods for percutaneous and hiatalapproaches for urethral or pelvic floor reconstruction and urethral orbladder neck stabilization or stabilization, suitable for use inconnection with the present invention, are disclosed in the copendingU.S. Patent Application entitled "Percutaneous and Hiatal Devices andMethods for use in Minimally Invasive Pelvic Surgery" U.S. patentapplication Ser. No. 09/023,965, filed simultaneously herewith, and theidentically titled U.S. Provisional Patent Application Ser. No.60/038,171, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference.

Preferred methods of securing the sling 42 in place may involveanchoring the sling 42 to a bone via a suture 88 and a bone anchor, ormay involve attaching the sling 42 to a suture 88 which passes through abone, such as the pubic bone. This preferred embodiment of the method ofattaching the sling 42 into place after it has been delivered into atissue cavity by the card 30 of the invention will be discussed below inconnection with other aspects of the present invention. It will beevident to those of ordinary skill in that art that the method of thisaspect of the invention will be applicable to the positioning of severalkinds of medical devices. Such medical devices may be secured into placeafter their positioning by one of several known techniques.

Another aspect of the invention provides an incision guide 50 (see FIG.5) for cutting a cavity between the urethra and the vagina 4, in thehiatal tissue. The incision guide 50 consists of a rigid catheter 52 anda cutter 54, and may also consist of several other accessories toenhance or vary the performance of the incision guide 50. The rigidcatheter 52 is a modified Foley-type catheter, preferably having a shaftof metal or other rigid material over the surface of the catheter.

The catheter 52 is inserted into the urethra and an integral bladderneck balloon 53 is inflated. (FIG. 3.) The rigid catheter 52 straightensthe urethra and extends externally to provide a guide for attachment ofdevices which advance parallel to the urethra along the central hiatusplane. The balloon 53 holds the catheter 52 in place. Such devices whichtrack along the rigid catheter 52 are used for dissecting the hiatus 2laterally between the urethra and the upper vaginal wall 8 from theproximal urethra. A number of different methods are contemplated.

The catheter 52 is therefore insertable into the urethra and is adaptedfor indicating the position of the bladder neck 47. The rigid catheter52 functions to expand and straighten the urethra, providing a fixedreference point in the soft tissue of the urethral floor and hiatalplane. This fixed reference function also facilitates a surgeon'sdetermination of the lateral position of the urethra by palpation, orwith any of several forms of instrumentation.

The catheter 52 is designed to be of sufficient length to reach to thebladder 46 and also to extend outside the body of the patient. Thecatheter 52 will preferably have graduation marks or other indicia 58thereon to indicate the distance from the surface of the distal urethrato the bladder neck 47 and the bladder 46. (FIG. 4.) The catheter 52,therefore, as it runs from the bladder neck 47 to the distal urethra andbeyond, provides access for mounting and guidance of other devices, suchas the cutter 54. (FIG. 5.)

The cutter 54 is used for forming the desired cavity at a position thatis a fixed distance from, and therefore parallel to, the urethra. Thecutter 54 has a longitudinal axis of similar dimensions to the catheter52, and has a cutting end 56 and a connecting end 57. The cutter 54 isadjustable at its connecting end 57 with the exterior portion of therigid catheter 52 and can slide along the catheter 52, thus providingtracking guidance for the cutter 54. (FIG. 5.)

The manner of attachment between the cutter 54 and catheter 52 willdetermine the amount of offset between the cavity and the urethra. Thepreferred distance of offset between the cutter 54 and the catheter 52is approximately 0.5 cm. This distance would in most patients positionthe cutter 54 to roughly bisect the distance between the upper vaginalwall 8 and the urethra. Because of the variability in the anatomy ofpatients, and the other ways in which this approach can be applied, apreferred range of offset may be from 0.25 cm to 0.75 cm. In otherembodiments a useful range may be from 0.1 cm to 0.9 cm. Again, becauseof the variability in patient anatomy, in some cases it may beadvantageous to further offset the cutter 54 from the catheter 52 by adistance of 1 cm or more.

The cutter 54, being adapted to articulate with and slide along the axisof the catheter 52, provides a means for creating a cavity in thevaginal hiatus 2. This cavity is in a predictable and optimally safeplane between the urethra and the upper vaginal wall 8. The desireddimensions of the cavity may vary widely depending on the anatomy of thepatient and the purpose for which the cavity is made. In some cases, apreferred cutter 54 for attachment to the catheter 52 is a needle 62.(FIG. 6a.) In other cases a preferred cutter 54 is a blade 64. (FIG.6b.)

A third preferred cutter 54 is a bipolar knife, providing lateraldissection of the vaginal hiatus 2 that is bloodless, by cutting andcoagulating the tissue simultaneously. With use of the bipolar knife, itis preferable to equip the metal portion of the catheter 52 withthermistors along its length, to measure the heat generated by thebipolar knife and provide temperature information to the surgeon. Oneembodiment of the bipolar knife, also known as the bipolar cutting loop,consists of a pair of wires, one flexible and one rigid, through which acurrent is passed to heat the loop.

Preferred dimensions of the cavity that is created may be from 1 to 3.5cm deep and may have a width ranging from the width of a needle 62 toapproximately 3.5 cm. The most preferred width for applications in whicha sling 42 is to be installed is approximately 2 to 4 cm. The preferreddepth of penetration of the cutter 54 is, of course, a function of theparticular anatomy of a given patient, and is to be determined by thesurgeon after insertion of the rigid catheter 52 and reference to theindicia 58 thereon.

Modified embodiments of the incision guide 50 include the attachment ofvarious other devices to further optimize the control that a surgeon mayexercise over the depth and direction of penetration of the cutter 54device. One such modification is to add one or more stops 60 to thedevice, as shown in FIG. 5. In one embodiment of this modification, onestop 60 is movably and lockably positioned on the catheter 52. This stop60 may have the form of a ring or a block, and may be locked at aparticular position of the catheter 52 by means of a thumb screw or aspring snap that articulates with the indicia 58 on the catheter 52 atvarious positions along its length. The stop 60 slides onto the end ofthe end of the catheter 52 and may be locked in a certain position onthe catheter 52 to prevent advancement of the cutter 54 past theposition of the stop 60. The cutter 54 may also have a block 61 intendedto abut the stop 60 that is placed on the catheter 52. Therefore thecutter 54 which slides along the catheter 52 may attach by means of astop block 61, or by other means of attachment that may similarlyfunction as a stop block 61.

This aspect of the invention provides a method for creating a cavity inthe vaginal hiatus 2. The method begins with insertion into the urethraof the rigid catheter 52. (FIG. 3.) The preferred catheter 52 is, asdiscussed above, provided with indicia 58 to indicate the position ofthe bladder neck 47. The catheter 52 extends from the distal urethra ofthe patient, providing a linear guide for the cutter 54. According tothe method, the position of the bladder neck 47 is determined. Next thecutter 54 is positioned on the catheter 52 and is advanced toward thepatient along the catheter 52 until the cutter 54 contacts andpenetrates the vaginal hiatus 2. (FIG. 5.) The cutter 54 is theninserted into the vaginal hiatus 2 to a predetermined depth, thuscreating a cavity in the vaginal hiatus 2 that does not extend to thebladder neck 47.

This method allows a surgeon to make an incision into the vaginal hiatus2 in a way that optimizes the safety, reproducibility, and reliabilityof the procedure. With a preferred embodiment of the incision guide 50as discussed above, the depth of insertion may be very preciselycontrolled, preventing damage to the bladder neck 47. Likewise, thedisplacement between the urethra and cutter 54 is maintained constant,thus assuring that creating the cavity will not compromise the urethraor the vaginal wall 8.

The various embodiments of the incision guide 50 also provide precisecontrol of the width of the incision. For example the incision width maybe that of a needle 62 (FIG. 6a) of a selected gauge, or it may be thewidth of a selected blade 64 (FIG. 6b), or it may be the widthdetermined by the dimensions and orientation of the wires in a bipolarknife. An additional benefit of the method of the invention is that,because the cutter 54 tracks along the rigid catheter 52, and thereforetracks along the urethra itself, there is a constant lateralrelationship between the dimensions of the pocket and the position ofthe urethra. This assures that the cavity will have the dimensions,orientation, and position to optimize placement of a device within thecavity.

The depth of incision and the distance of offset between the urethra andthe cavity thus created is determined by the dimensions of theattachment block 61 between the cutter 54 and the rigid catheter 52.(FIG. 5.) In a preferred embodiment of the invention, wherein the rigidcatheter 52 has attached thereto a stop 60, the stop 60 may be preciselypositioned to prevent the advancing of the cutter 54 to a depth thatwould create a risk of damaging structures of the bladder 46.

Where the rigid catheter 52 is also equipped with thermistors, providingtemperature feedback for safe use of the bipolar knife, an incision maybe made rapidly and bloodlessly. Because of the potential damage causedby a bipolar knife in tissue close to critical structures such as thebladder 46 and urethra, many physicians would ordinarily hesitate tomake incisions with such an instrument. However, this concern isaddressed through the use of the present method because the orientationof the cutter 54 and the catheter 52 provides very precise control overthe offset between the cutter 54 and the catheter 52 as well as over thedepth of penetration of the cutter 54.

The incision guide 50 may be combined with the insert card 30 to providea method for inserting a medical device into a cavity. In this method atissue cavity is created according to the steps of the method providedimmediately above, and a card 30 supporting a medical device is insertedinto the cavity. The medical device may be a pharmacologically activeimplant, a prosthetic balloon, or a therapeutic device. In a preferredembodiment of this method, the medical device is a urethral sling 42, asin FIG. 2e. After the cavity is created with use of the incision guide50, the card 30 may be inserted directly into the cavity, depending onthe dimensions of the card 30 and the cavity. The medical device may besecured within the cavity by a variety of means, after which the card 30may be withdrawn. Alternatively the card 30 may be withdrawn before thedevice is secured.

An additional embodiment of the method of the invention combines use ofthe dilator 10 of the invention together with the incision guide 50 andthe card 30. A cavity is created with use of the incision guide 50, asexplained above, and then the cavity is stabilized and further definedby insertion of the spreader 12, which is then moved to the openposition, as in FIG. 2d. With the spreader 12 in the open position, thecavity may be stretched, if necessary. The cavity is also provided withtracks along which the card 30 may easily slide to enter the cavity, asin FIGS. 2e and 2f. Thus, the invention contemplates the use of thedevices of the invention alone or in combination, in order to achievethe desired result.

With reference to FIGS. 7, 8, 9 and 10 in another aspect, the presentinvention provides a driver 70 for driving a bone-piercing guide 84through the pubic bone. Originally, passing a suture through the pubicbone was done by drilling a hole through the generally anterior portionof the pubic bone using a drill guide attached to a stabilizer andvaginal retractor device. A suture was then passed through the drilledhole with a suture passer. The present invention does not require theuse of a drill and is capable of creating small passages through thepubic bone, sufficient to allow passage of a suture through the bone.The pubic bone is particularly well suited for this adaptation becauseit is relatively easily pierced, due to its low density.

The driver 70 of the invention may be described as having four basicparts: a first jaw 72, a slide bar 80, a second jaw 82, and abone-piercing guide 84. (FIG. 7.) The first jaw 72 has a distal end 74and a proximal end 78. The distal end 74 is adapted for inserting into atissue cavity and the proximal end 78 of the first jaw 72 is attached tothe slide bar 80. The slide bar 80 connects the first or fixed jaw 72with the second or moveable jaw 82. The second jaw 82 slides along theslide bar 80, with a releasable ratcheting action, toward the first jaw72. The bone-piercing guide 84 attaches to the second jaw 82, andadvances toward the first jaw 72 as the second jaw 82 is ratcheted alongthe slide bar 80.

A stop 86 on the slide bar 80 prevents further closing of the jaws oncethe sharp end 96 of the cannula 90 exits the bone and is even with thefirst jaw 72. The first jaw 72 has a slot 76 so that the sharp end 96 ofthe cannula 90 does not actually contact it when exiting the bone. (FIG.8.) The driver 70 may be equipped with a double cannula jaw (not shown)so that parallel passages may be created through the bonesimultaneously.

It is the function of the first or fixed jaw 72 inside a tissue cavityto provide a counterpressure on the bone opposite the pressure appliedby the bone-piercing guide 84. Accordingly, the distal end 74 of thefirst jaw 72 may have a shape adapted to provide positions that canappress the inferior region of the pubic bone 45 lateral to the pubicsymphysis without crushing the urethra 6. Such a configuration of thedistal end 74 of the first jaw 72 is shown in cross section in FIGS. 24aand b, 26a and b, and 27a; a detail view of a portion of the edge of thedistal end 74 of the first jaw 72 is shown in FIG. 25. In these figures,the distal end 74 comprises a tongue 114 with a central depression 136and elevated edges 138. The edges 138 may have contact pins 140 adaptedfor piercing the tissue lying between the pubic bone 45 and the elevatededge 138 of the tongue 114. At the elevated edge 138 there also may be agap 144 through which a guide 84 may pass without contacting the tongue114.

Any device with opposing jaws having one jaw adapted for insertion intoa tissue cavity may preferably have a tongue configuration as describedabove. The choice of a desirable configuration of the distal end 74 ofthe first jaw 72 may be determined by one of ordinary skill in the art,taking into account anatomical considerations, the particular procedureinvolved, and the like.

The pubic bone is an especially important structure for piercing insurgical applications. This is true for at least two reasons: the firstis that there are soft tissue structures in the proximity of the pubicbone whose dimension or displacement can result in several medicalproblems. The second reason is that the pubic bone is a relatively lowdensity bone and therefore may be pierced without the application ofundue force, if the force is properly oriented. The fact that the pubicbone may be pierced creates the possibility of stabilizing a soft tissuestructure near the pubic bone by attaching a device or a suture to thesoft tissue structure and stabilizing it by attachment to the relativelyimmovable pubic bone. In addition, by piercing through the bone, thesuture locking and tissue securing method may be accomplished from thesuperior/anterior bone surface, which is much more accessible than theposterior/inferior surface. The prior need to work near or at theposterior/inferior surface of the pubic bone arose from the proximity ofthis surface to the structures most often sought to be stabilized. Withthe methods and devices of the present invention, however, passage ofsuture through the pubic bone combines the desired proximity tostructures beneath the bone, with the convenience and simplicity ofintroducing and securing suture through the upper surface of the bone.Therefore the bone driver 70 of the present invention provides a deviceof potentially wide applicability for stabilizing structures of thepelvis, particularly in reconstruction and stabilization of the urethraland pelvic floor.

Alternative approaches to stabilizing structures of the urethral andpelvic floor or other soft structures of the pelvis by attachment to afixed reference tissue have relied on drilling a hole into the surfaceof a bone and placing into the hole a bone anchor to which a suture isattached. The difference between such approaches and the presentapproach is that the present invention allows a much smaller opening tobe made. This opening traverses the bone rather than being simply on thesurface of the bone. Through this much smaller passage may be passed asuture, without the need of a bone anchor. As used herein, a bone anchoris a device that attaches a suture to the surface of a bone, wherein thesuture thus attached does not pass through the bone. The presentinvention provides devices for connecting sutures to the bone, whereinthe sutures have passed through the bone. This is the basis for thedistinction, made in this specification, between "bone suture fasteners"and "bone anchors."

A preferred embodiment of the driver 70 of the present inventionprovides a first jaw 72, whose distal end 74 is adapted for insertioninto the vagina 4. (FIG. 8.) An alternative embodiment provides a jaw 72whose distal end 74 is adapted for insertion into a cavity created inthe vaginal hiatus 2 as discussed above. A further embodiment mayprovide a first jaw 72 whose distal end 74 is adapted for insertion intoa transvaginally created cavity in the hiatal plane.

As alternative embodiments to the preferred ratcheting motion of thesecond jaw 82 toward the first jaw 72, the jaws also may be broughttogether by various other mechanical advancing means, such as a threadedbar, in combination with a thumb screw. The bone-piercing guide 84 maybe hollow or solid; examples of bone-piercing guides 84 may be a needle,a cannula, or a solid rod. The guide 84 also may be a cannula with aremovable obturator, so that the guide 84 behaves essentially as a solidrod while piercing the bone, but then can be converted to a hollowconfiguration for passing various devices along the lumen thereof. Apreferred cannula size is believed to be approximately 14 gage. In apreferred embodiment the guide 84 is sharpened and relatively stiff,thus minimizing the possibility that the guide 84 will bend or skimalong the surface of the bone, and increasing the tendency of the guide84 to pierce directly into the bone along a straight line between thefirst jaw 72 and the second jaw 82.

An advantage of the bone-piercing guide driver 70 is that the devicedoes not require that a hole be drilled through the bone. The passageremains open and completely accessible until the cannula 90 is removed,whereas the drilled hole is often lost once the drill bit is removed.Also, the drill requires additional incisions on both sides of the pubicbone to expose the bone, otherwise tissue is twisted around the drill asit turns.

The driver 70 of this aspect of the invention may be used by itself orin combination with devices of other aspects of the invention.Accordingly, the driver 70 may be used in connection with the dilator10, for example, by creating a tissue cavity with the dilator 10 andthen placing the first jaw 72 of the driver 70 in thetissue cavitycreated by the dilator 10. Likewise a tissue cavity may be created bythe incision guide 50 and the first jaw 72 of the driver 70 may beplaced inside the cavity thus created. Furthermore, the insert card 30,capable of introducing into a cavity a medical device, also may be usedin connection with the driver 70 of the invention. In this particularcombination the first jaw 72 of the driver 70 may be configured tosupport the card 30 or connect with the articulation opening 40 of thecard 30 such that introduction of the first jaw 72 into the tissuecavity places the device in the appropriate position within the cavity.Subsequent operation of the driver 70 directly positions thebone-piercing guide 84 in the proper orientation with respect to thedevice supported on the card 30. Therefore, use of the driver 70 incombination with devices of other aspects of the present invention mayresult in several beneficial methods for surgery on the urethral floorand other structures of the pelvis.

This method creates a path through the pubic bone, which path is usefulfor passing sutures 88 or medical devices through the pubic bone. Thereare several alternative embodiments of this method. In one embodimentthe guide 84 is passed through the bone to create a path through thebone and then the guide 84 is removed, leaving the path in the bone andin the tissue. After removal of the guide 84, medical devices such as asuture 88, a suture passer, or a suture securing device 126 may bepassed along the path through the bone that was created by thebone-piercing guide 84. Any device capable of passing a suture throughtissue may be used in accordance with the present invention, includingthe suture passers and methods of their use, disclosed in U.S. Pat. No.5,611,515, issued Mar. 18, 1997 to Benderev et al., the disclosure ofwhich is incorporated herein by reference.

The driver 70 of the invention also may be used in a differentorientation such that the movable jaw is adapted for insertion into atissue cavity and for driving a device into the pubic bone from theposterior-inferior surface. As an example of a preferred embodiment, asling 42 with pre-attached push-in bone anchors (not shown) ispositioned on an insert card 30 and is placed into a tissue cavity withthe assistance of the dilator 10 or the incision guide 50 of theinvention, or by using both in combination. Next, the push-in anchorsare oriented to face and contact the pubic bone. Finally, the movablejaw of the driver 70 is placed below the push-in anchors of the sling 42and the fixed jaw of the driver 70 is placed against the patient'sabdominal surface such that the pubic bone lies between the fixed jawand the movable jaw. The movable jaw is then advanced toward the fixedjaw such that the push-in bone anchors are driven into theposterior-inferior surface of the pubic bone and the sling 42 is securedin place.

Other means of securing a sling 42 in place by using push-in type boneanchors are also contemplated in the invention. For example, a pivotingor otherwise manipulable tongue or insert card 30 that supports andpositions the sling 42 may be forcefully angled against the pubic bonesufficient to drive into the pubic bone the push-in type anchors fromthe posterior-inferior surface of the bone. In another embodiment,cannulas 90 are driven through the bone, both left and right of themidline, such that a path into the pubic bone is provided for initialguidance of push-in anchors. As the cannulas 90 on either side of themidline are withdrawn from the pubic bone, the push-in anchors (notshown) are pressed upward against the bone and initially follow the pathof the cannulas 90. Thus, a guide hole is created by the cannulas 90 forthe anchors. The application of additional upward pressure seats theanchors and the sling 42 is secured in place.

A preferred embodiment of the invention uses a cannula 90 as thebone-piercing guide 84. (FIG. 9a.) The lumen of the cannula 90constitutes a path through the tissue and through the pubic bone.Accordingly, the path through the lumen of the cannula 90 allows passageof sutures 88 or other devices through the bone without the difficultyof locating the path through the bone. (FIG. 9b.) In this method acannula 90 (FIG. 9a) is attached to the driver 70, as shown in FIG. 8,and the first jaw 72 of the driver 70 is placed inside the tissuecavity, the pubic bone is located and the driver 70 is positioned toalign the pubic bone between the first jaw 72 and the second jaw 82. Thesecond jaw 82 is then advanced toward the first jaw 72, pushing thecannula 90 through the pubic bone and through the soft tissue on eitherside of the pubic bone. Subsequently, a suture 88 is passed through thecannula 90 and into the cavity.

Depending on the internal diameter of the cannula 90, other devices alsomay be passed inside the lumen. For example, devices such as a suturepasser, a quick connect device, and the like, may be passed through acannula 90 of sufficient internal diameter. In a preferred embodiment,the cannula 90 has a sharpened tip 96, and has a relatively high degreeof stiffness.

This aspect of the invention provides a method of pelvic surgery thatuses the driver 70 of the invention wherein the guide 84 of the driver70 is a cannula 90. The first jaw 72 of the driver 70 is inserted intothe tissue cavity, and the pubic bone is located. The driver 70 ispositioned to align the pubic bone between the first jaw 72 of thedriver 70 and the second jaw 82 of the driver 70. The second jaw 82 isadvanced toward the first jaw 72, forcing the cannula 90 into the tissueand through the pubic bone. After the cannula 90 passes through thepubic bone it is further advanced along the same line into the cavity,approaching the first jaw 72 of the driver 70. Alternatively, a firstcannula 90 can be used to pierce the pubic bone, and a second cannula 90may be passed within the lumen of the first cannula 90 to its finalposition on either side of the urethra. A suture 88 is then passed intothe lumen of the cannula 90 and is advanced through the cannula 90 untilit enters the tissue cavity. The end of the suture 88 that is in thetissue cavity is secured there and the second end of the suture 88 issecured to the pubic bone. The attachment thus created between the pubicbone and the tissue cavity stabilizes the tissue cavity and structuresnearby. (FIG. 10b.)

There exist several alternative embodiments of the method of this aspectof the invention. In one embodiment, the cannula 90 is removed after thefirst end of the suture 88 passes through the cannula 90 and into thecavity. The cannula 90 is therefore withdrawn, leaving both ends of thesuture 88 on opposite sides of the pubic bone prior to the attachment ofeither end of the suture 88 in its place. In another embodiment of thismethod, the suture 88 is attached within the cavity and then the cannula90 is withdrawn, followed by the attachment of the second end of thesuture 88 to the bone.

The mode of and purpose for attachment of the suture 88 within thecavity is variable, and the factors affecting the selection of the modewill be appreciated by one of ordinary skill in the art. For example,the suture 88 may be affixed in the cavity with one or more stitches 92(FIG. 10a) to tissue therein. Alternatively, the suture 88 may beattached to a device for distribution of pressure across relativelywidened area of tissue, such as suture button 94 or a sling 42. (FIG.9b.) The suture 88 also may be attached to a staple (not shown) withinthe cavity, such that the staple anchors the suture 88, so thatappropriate tension on the suture 88 elevates the tissue to which thestaple is attached.

Without the use of an additional device, attaching the suture 88 totissue within the cavity may make possible amelioration of certainincontinence conditions that arise from hypermobility of the urethra orfrom intrinsic sphincter deficiency. This is done simply by attachingthe suture 88 to tissue and then providing an appropriate tension. Thistends to elevate the tissue, which therefore elevates the urethra atthat position a distance A (compare FIG. 10a to 10b), eliminating oreasing the condition causing urinary incontinence.

An alternative embodiment of this aspect of the invention uses thedriver 70 to insert a cannula 90 into the tissue cavity by passing itthrough the pubic bone as described above. In this embodiment, however,the end of the suture 88 which is advanced through the cannula 90 andinto the tissue cavity is passed through a structure 93 within thetissue cavity. It is subsequently passed back out of the cavity andsecured to the pubic bone, along with the second end of the suture 88.In this embodiment of the invention, the structure 93 through which thesuture 88 may be passed include a suture button 94 or grid, a sling 42,and a tissue mass adjacent the cavity (creating stitches 92). Thecannula 90 advantageously has a sharpened end 96 and a reinforcedstiffness, to facilitate its passage in a straight line through the boneand to minimize skimming along the surface of the bone. Further, forembodiments of this method, the cavity is preferably a cavity in thevaginal hiatus 2 created according to one of the other methods of thisinvention. The cavity also may be the vagina 4, or a cavity in thehiatal tissue created transvaginally.

This method is advantageous particularly for the stitching of a tissuemass for stabilization of the urethra floor or other pelvic structures.(FIG. 10b.) Because the suture 88 enters and then again exits the tissuecavity, it may be passed through several stitching 92 points in thetissue before it is withdrawn through the cannula 90 and out to thepubic bone. Both ends of the suture 88 may be secured to the pubic bonein a variety of ways, many of which will be explained in detail below.

This method may be advantageously practiced with the additionalassistance of a suture passer device. The suture passer is advancedthrough the cannula 90 and into the tissue cavity upon completion of thedesired number of sutured stitches 92 within the cavity, the suture 88is grasped by the suture passer, and withdrawn through the cannula 90 toproperly position it at the surface of the pubic bone for attachment.This method may be preferably used for tensioning, stabilization, orelevation of a tissue mass adjacent to the urethra or adjacent toanother soft tissue structure in the pelvis that may be in need ofstabilization or reorientation. The fact that the suture 88 is securedto the bone creates a stability for the target tissue mass that isdesirable in many cases. It also may be desirable to use this method insecuring in a tissue cavity a pharmacological implant, a prostheticdevice, or a therapeutic device.

This aspect of the invention provides an additional method for pelvicsurgery wherein the driver 70 is used to pass a guide 84 through thepubic bone along a first path, proceeding into the tissue cavity at afirst position. A suture 88 is then passed through the cannula 90 intothe cavity. The driver 70 is then used to create a second path throughthe pubic bone, arriving at a second location within the tissue cavity.The suture 88 which was passed along the first path through the pubicbone and into the cavity may then be passed along the second path out ofthe cavity and through the pubic bone at the second position. Both endsof the suture 88 may then be secured to the pubic bone. In this method,the suture 88 that passes through the cavity may preferably also bepassed through a tissue mass of the cavity, a suture button 94 or agrid, or a sling 42, prior to exiting the cavity along the second paththrough the pubic bone. Alternatively, by simply passing the suture 88through the cavity and then tensioning it properly, the suture 88 mayserve to elevate the tissue mass and stabilize the structures adjacentthereto.

The invention thus provides several alternatives for stabilizingstructures of the urethral floor or other structures of the pelvis bysecuring the soft tissues to the pubic bone. The methods differprimarily in the paths along which the suture 88 is advanced. However,whether one chooses to advance the suture 88 into the cavity and anchorone end of the suture 88 therein, or to advance the suture 88 into thecavity and return it out of the cavity along one path, or to advance thesuture 88 into a cavity along a first path and retract it from thecavity along a second path, all three methods may be adapted to severalvariations. In all of these methods, the tissue cavity may be the vagina4. It also may be a cavity in the hiatal tissue created, for example,either by the dilator 10 or by the incision guide 50 of the presentinvention as previously described. Alternatively, the cavity may be acavity created transvaginally by opening a pocket in the hiatal tissuethrough the upper vaginal wall 8.

Furthermore, in any of the methods of this aspect of the invention, apreferred embodiment would perform the method on both the right and leftside of the midline of the patient, to equally distribute points ofattachment on either side of the urethra. Likewise, another preferredembodiment of any of these three methods would involve the additionalstep of tensioning the suture 88 prior to its attachment to the pubicbone. Suture tensioning may be accomplished in a variety of ways, one ofwhich is with the use of suture tensioning device. This type of devicehas a handle with which the surgeon can place the device next to thelocation where the suture 88 will be tied. Attached to the handle isanother structure of the suture tensioner around which the suture 88will be wrapped, and upon which the suture 88 may be tied. The externaldimensions of this structure control the degree of slack that the suture88 retains after the suture 88 is tied. Therefore, based on the lineardistance between the bone and the soft tissue sought to be stabilized,as well as the amount of slack needed to achieve a particular objectivefor a given patient, a suture tensioner with an appropriate diameterwill be selected so as to provide the proper amount of tension in theconnection between the bone and the soft tissue.

The several methods of passing a suture 88 through one or more paths inthe pubic bone may be particularly applied to a method for stabilizing aurethral sling 42 relative to the pubic bone. In this method a cavity iscreated in the vaginal hiatus 2. The cavity may preferably be made usingthe dilator 10 or the incision guide 50 of the present invention, orboth in combination. The dimensions of the cavity and the amount ofoffset from the urethra will be determined according to the size of thesling 42 that is needed, the dimensions of the patient's urethra, andthe surgeon's preference. After the cavity is formed, guide 84 is driventhrough the pubic bone to create a path. This is done by placing thedistal end 74 of the first jaw 72 of the driver 70 into the tissuecavity followed by positioning the second jaw 82 of the driver 70, suchthat the pubic bone lies in a straight line between the first jaw 72 andsecond jaw 82. A urethral sling 42 is placed into the cavity eitherbefore or after the cannula 90 is driven through the pubic bone and intothe cavity. The sling 42 may be placed into the cavity with the aid ofan insert card 30 as discussed above, or by other surgical proceduresknown in the art. With the cannula 90 in the cavity adjacent the sling42, the suture 88 is attached to the sling 42 and to the pubic bone.

This method is embodied in a technique wherein the cannula 90 iswithdrawn before the suture 88 is secured on either end. The method alsocontemplates withdrawal of the cannula 90 after the sling 42 is securedbut before the suture 88 is secured to the bone. In addition toattaching the sling 42 with sutures 88, this method contemplates anindirect attachment of the sling 42 to sutures 88 by directly attachingthe sling 42 to devices which are themselves attached to sutures 88. Anexample of such an indirect attachment to a suture 88 is a securingdevice 126 as disclosed herein. This method may advantageously involveuse of the devices of other aspects of the present invention. The tissuecavity may be made either by the dilator 10 or the incision guide 50, orby using both together, and the sling 42 may be delivered to its properposition in the cavity with aid of the insert card 30 as discussedabove. Depending on the particular manner in which the insert card 30articulates with a driver 70, the cooperative use of the insert card 30may precisely position the sling 42. This will cause the bone-piercingguide 84 to meet the sling 42 at the appropriate straight line positionas is desirable in this method.

Another aspect of this invention provides a driver frame assembly 100.The driver frame assembly 100 FIG. 13, serves to align, support andstabilize both the patient's pelvis and the devices of the invention inprocedures for reconstructing the urethral and pelvic floor or forperforming other methods of pelvic surgery. The driver frame assembly100 has an upper clamp 102, a rigid catheter 52, a cavity tongue 114, alower clamp 120, and at least one driver 70. The upper clamp 102 of thedriver frame assembly 100 has a head portion 104, a descending arm 106and a base portion 108. The head portion 104 has a compression foot 110that is used to compress a patient's abdominal surface against the pubicbone. The compression foot 110 has stabilizing pins 112 that extenddownward therefrom and that pierce the patient's skin 48, penetratingthe abdomen at a position adjacent to the superior surface of the pubicbone. The compression foot 110 may be pressed against the abdomen of thepatient with, for example, a threaded screwing mechanism, a ratchetingor piston mechanism, or a linkage mechanism. The stabilizing pins 112are designed to be of a length that makes it impossible for the pins 112to cause damage to any abdominal or pelvic organs. At the same time thestabilizing pins 112 have dimensions making them sufficiently strong toresist the lateral forces exerted with operation of the driver 70.

The rigid catheter 52 portion of the driver frame assembly 100 functionsmuch as the rigid catheter 52 of the incision guide 50, as discussedabove. The catheter 52 is intended to straighten and elongate theurethra, as well as to assist in identifying the position of theurethra, the bladder 46, and bladder neck 47. The rigid catheter 52 isof sufficient length to extend outward beyond the distal urethra of thepatient. This external extension of the rigid catheter 52 provides astructure with which the frame assembly may articulate and attach. (FIG.11.)

The tongue 114 portion of the driver frame assembly 100 is adapted forinsertion into a tissue cavity, such as the vagina 4 or a hiatal cavityprepared prior to insertion of the tongue 114. In a preferredembodiment, the tongue 114 has a central depression 136 and elevatededges 138 (FIG. 12b), allowing compression of the tongue 114 sidesagainst the inferior surface of the pubic bone to counter the pressureof the compression foot 110. Because of the shape of the tongue 114,this type of pressure may be applied without crushing the urethra. Thetongue may also have a relatively broad elevated edge 138 contact pins140 for contacting the pubic bone. (FIGS. 24 and 25.) A flat tongue 114does not allow the application of a strong counterpressure against thebone, because of the potential damage to the urethra. (FIG. 12a.) Thetongue 114 has a first end 116 for inserting into the cavity, and asecond end 118 which is adapted for articulating with the base portion108 of the upper clamp 102. This articulation may be, for example, bymeans of a threaded connector 107 that joins the tongue 114 to the baseportion 108 of the upper clamp 102 (FIG. 15.).

The lower clamp 120 of the driver frame assembly 100 has a buttock plate122 for insertion beneath the patient such that the patient's weightrests on the plate to further secure the frame assembly. Attached to thebuttock plate 122 is an ascending arm 124 that is adapted forarticulating with the base portion 108 of the upper clamp 102. (FIG.13.) Thus, the upper clamp 102 attaches to the rigid catheter 52 and thecavity tongue 114, and then the upper clamp 102 also attaches to thelower clamp 120, which is anchored under the patient's body. The effectof these multiple attachments is to compress a patient's pelvic regionto provide stability for operation of the bone-piercing guide driver 70as well as to enhance the straight line precision of driving a guide 84through the pubic bone.

In a preferred embodiment, an insert card 30 capable of supporting amedical device is an additional component of the driver frame assembly100. (FIG. 18.) In such an embodiment, the card 30 adapted to slidealong the tongue 114 to reach the proper position within the cavity. Thearticulation opening 40 of the card 30 also may be used for attachmentor positional control of the card 30 with respect to the driver frameassembly 100.

The driver 70 portion of the driver frame assembly 100 is similar to thedriver 70 of a previous aspect of the invention as discussed above. Thedriver 70 of this aspect of the invention, however, does differ in therespect that it attaches to the driver frame assembly 100 via the slidebar 80 of the driver 70. Accordingly, the driver 70 of this aspect ofthe invention has the slide bar 80 and the moveable jaw, but does nothave its own immovable or first jaw 72. However, upon attachment of thedriver 70 to the driver frame assembly 100, both the tongue 114 portionand the buttock plate 122 portion of the driver frame assembly 100 cansimultaneously function as fixed jaws toward which the immovable jawadvances as it moves along the slide bar 80. (FIG. 15.)

As mentioned above, the function of the first or fixed jaw is to providecounterpressure to the pressure applied to the pubic bone by theadvancement of the guide 84 through the pubic bone. The preferred driver70 portion of the driver frame assembly 100 has two positions forattachment of bone-piercing guides 84 to the second, or movable, jaw 72.(FIG. 14.) These positions are left and right of center, being laterallyspaced to provide sufficient offset from the patient's midline so as toprevent any contact of the bone-piercing guides 84 with the urethra.Thus, the driver 70 of the assembly is intended to simultaneouslyadvance two separate bone-piercing guides 84 through the pubic bone, oneleft and one right of the patient's midline, as shown in FIG. 16.

This aspect of the invention provides a method for reconstruction of theurethral and pelvic floor or for stabilizing a tissue of the pelvicregion. In this method a rigid catheter 52 is placed in the urethra sothat the urethra is elongated and straightened. (FIG. 11.) The catheter52 also aids in determining the position of the bladder 46 and thebladder neck 47. The tongue 114 of the driver frame assembly 100 isplaced into the tissue cavity, and also may be attached to the rigidcatheter 52. (See FIGS. 11 and 12.) Preferably an insert card 30 holdinga medical device, for example, a urethral sling 42, is inserted into thecavity using the tongue 114 as a guide. (FIG. 18.) The upper clamp 102is attached to the tongue 114 and to the catheter 52, and thecompression foot 110 is compressed against the patient's abdomen, afterpalpation to determine the proper position of the stabilizing pins 112relative to the superior surface of the pubic bone. The compression foot110 is tightened against the patient's abdomen to prevent slipping ofthe bone-piercing guide 84, and to further immobilize the soft tissuesof the pelvis. (FIG. 11). Further stabilization is achieved withattachment of the lower clamp 120 which is done by sliding the buttockplate 122 beneath the patient and firmly attaching the ascending arm 124of the lower clamp 120 to the base portion 108 of the upper clamp 102.(FIG. 13.)

With the driver frame assembly 100 properly installed along thepatient's midline, the driver 70 portion of the driver frame assembly100 may be mounted on the descending arm 106 of the upper clamp 102.(FIG. 13.) Care is taken to assure that the bone-piercing guides 84 ofthe driver 70 are positioned such that they will enter the pubic bone.Then the second removable jaw of the driver 70 is advanced downwardalong the slide bar 80 and the guides 84 are advanced into the abdominalsurface and through the pubic bone, emerging within the tissue cavitynear the medical device supported on the card 30. (FIG. 15.)

In a preferred example, the bone-piercing guides 84 are cannulas 90 andthe medical device supported on the card 30 is a sling 42. (FIGS. 17 and18.) In such an embodiment, the proximity of the cannulas 90 with thesling 42 permits suturing or other attachment through the lumen on thecannula 90 to the desired location on the urethral sling 42. (FIG. 19.)After attachment of suture 88 directly or indirectly (see FIGS. 21-23)to the sling 42, the cannulas 90 are removed, leaving behind the suture88, which is then secured to the pubic bone. (FIG. 27.)

In another embodiment of this aspect of the invention, a concaveinsertion tongue 114 is used to provide counterpressure for drivingcannulas 90 through the pubic bone 45. The concave tongue 114 isinserted into a cavity, such as, for example, a hiatal cavity or thevagina 4, and the compression foot 110 of the driver frame assembly 100is placed against the patent's pubic bone 45. (FIG. 24a.) The concavetongue has a central depression 136 and elevated edges 138, allowing theedges 138 of the tongue 114 to provide counterpressure to theposterior/inferior surface of the pubic bone 45, while the compressionfoot 110 and the cannulas 90 apply pressure to the opposite(anterior/superior) surface of the bone 45. (FIG. 24b.)

The central depression 136 of the tongue 114 prevents the urethra 6 frombeing crushed upon application of counter pressure on the bone 45 byelevated edge 138 of the tongue 114. (FIG. 24b.) The edge of the tonguemay also have a gap 144 to allow the cannula 90 to pass through theplane of the elevated edge 138 without the cannula 90 impacting againstthe tongue 114. The edge 138 may also have contact pins 140 of aconfiguration and position to pierce through soft tissue and fascia tocontact the surface of the pubic bone 45 and prevent slippage of thetongue 114. (FIG. 25.)

When pressure is applied to the opposite sides of the bone 45, as shownin FIG. 24b, the cannulas 90 are driven through the pubic bone 45 andinto the cavity. (FIG. 26a.) Suture 88 or other devices may be passedthrough the cannulas 90 and into the cavity. (FIG. 26b.) The suture 88may be attached within the cavity either by stitches 92 or by attachingthe suture 88 to a suture button 94. (FIG. 26b.)

After proper attachment of the suture 88 within the cavity, the pressureon both sides of the bone 45 is released, and the compression foot 110is raised. (FIG. 27a.) The tongue 114 is removed from the cavity, andthe sutures attached therein are fastened to the bone 45 with, forexample, either a bone eyelet 150 or a bone suture fastener 170. Theurethra 6 is elevated by the tension that is applied to the sutures 88in the step of fastening the sutures 88 to the bone 45. The resultingelevation of the urethra 6 is shown as distance B in FIGS. 27a and 27b.

The advantage of the method of this aspect of the invention is that thedriver frame assembly 100, if properly installed, provides rigidity tothe driver 70 to allow for highly accurate straight line passage of abone-piercing guide 84 through the pubic bone and to a target sightwithin the soft tissue. Because the driver 70 is able to advance twodifferent guides 84 through the bone at the same time, and because thecontact between the guide 84 and the sling 42 is relatively precise, theentire procedure can be done very rapidly and with minimal invasioncompared with other procedures used to achieve a similar objective. Inaddition, the method of this aspect of the invention, being minimallyinvasive, greatly reduces the risk of infection arising from theprocedure. Also reduced is the number of incisions, resulting in ashorter recovery time for the patient and less scarring, since theexternal abdominal wounds are all puncture wounds, and the only incisionis a relatively small incision or a knife stick in the vaginal hiatus 2or in the upper vaginal wall 8. In a preferred embodiment of this aspectof the invention, the sutures 88 which pass through the bone are securedto the bone after being tensioned with a suture tensioning device asdiscussed above.

Another aspect of the invention provides a system for attaching urethralsling 42 to a suture 88 as shown in FIGS. 21-23. The system includes aurethral sling 42 and a connector 130; the urethral sling 42 has a ringmember 44 attached thereto (FIGS. 29-30) and the connector 130 isadapted to cooperate with the ring member 44 to permit unidirectionalpassage of the connector 130 through the ring member 44 (FIGS. 21-23,32-35). The ring member 44 and the connector 130 further cooperate toprevent retrograde movement of the connector 130 through the ring member44.

The invention contemplates several embodiments both of the ring member44 and of the connector 130. The ring member 44 may be as simple as ahole in an appropriate part of the sling 42, suited for passagetherethrough by a connector 130. (FIGS. 33-35.) The ring member 44 alsomay be a more elaborate structure, such as a reinforced ring withflanges 142 protruding into the central opening 128 of the ring member44. (FIGS. 29, 30, 32.)

In a preferred embodiment, the connector 130 has a conical tip 131attached to a cylindrical portion 133 behind the tip 131 to which asuture 88 may attach. This embodiment is referred to as the arrowheadconnector 132. (FIG. 32.) The cylindrical portion 133 behind the tip 131has a smaller circumference than the widest part of the conical tip 131,such that there is a substantially flat shoulder 129 behind the tip 131.Accordingly, the arrowhead connector 132 is adapted for cooperating withthe reinforced ring member 44 having flanges 142 that protrude into thecentral opening 128. As the tip 131 penetrates the central opening 128,the flanges 142 move aside, allowing passage of the tip 131. However,once the entire conical portion of the tip 131 has passed through thecentral opening 128, the flanges 142 return to their initial orientationaround the central opening 128 and rest against the shoulder 129,resisting retrograde movement of the connector 130 through the ringmember 44. (FIGS. 22, 23, 30, 32.) Since the cylindrical portion 133behind the shoulder 129 of the arrowhead connector 132 has a means forconnecting to a suture 88, the passage of the connector 130 through thering member 44 creates a connection between the suture 88 and the sling42. By this method of connecting suture 88 to sling 42, there is no needfor stitching or tying knots to the sling 42, which greatly simplifiesand accelerates the securing procedure.

Another preferred embodiment of the securing device 126 has a connector130 with two perpendicular cylindrical members 135, 137 wherein themembers 135, 137 are substantially flexibly attached one to the other ata flexible joint 139. (FIG. 34.) The rear cylinder 135 has a means ofattaching to a suture 88, while the leading cylinder 137 is adapted forpassage through the ring member 44. As this embodiment of the connector130, referred to herein as the T connector 134, is inserted into acannula 90 for advancement toward the sling 42, the perpendicularitybetween the two cylindrical members 135, 137 is distorted, and theleading cylinder 137 assumes a position that is more closely parallel,rather than perpendicular, to the rearward cylinder 135. (FIG. 35.)However, after the T connector 134 has passed through the cannula 90 andthe leading cylinder 137 of the T connector 134 has also passed throughthe ring member 44 of the sling 42, the angular relationship between thetwo cylindrical members 135, 137 reverts to perpendicular. (FIG. 33.) Inthis conformation, the connector 130 may not pass back through the ringmember 44, and a secure connection between the suture 88 and the sling42 is therefore established.

This aspect of the invention provides a method for simple, minimallyinvasive placement and securing of a sling 42 in a tissue cavity. Atissue cavity, such as a cavity in the hiatal tissue, is created by useof, for example, the dilator 10 or the incision guide 50 of theinvention. Alternatively an existing tissue cavity, such as the vagina4, may be selected for placement of the sling 42. In addition, a tissuecavity in the hiatal tissue may be created by inserting a dilator 10 oran incision guide 50 through the upper vaginal wall 8. A sling 42 isthen placed into the cavity in its desired location. This step ispreferably performed with the use of the insert card 30 of theinvention, wherein the insert card 30 carries and supports the sling 42in its appropriate position within the cavity until it secured there.(FIG. 18.)

A cannula 90 is driven through the pubic bone using, for example, eitherthe driver 70 of the invention or the driver frame assembly 100 of theinvention. (FIG. 18.) The cannula 90 is then further driven throughtissue until it approaches and aligns with the sling 42, (FIG. 19.)which is equipped with ring members 44. A connector 130 attached to thesuture 88 is then inserted into the lumen of the cannula 90 and advancedtherethrough until it contacts with and passes through the ring member44 of the sling 42. (FIGS. 20, 21, 22.) At this point, the suture 88 istested for the integrity of the connection between the connector 130 andthe ring member 44, and the cannula 90 is withdrawn from the pubic bone.The suture 88 may then be appropriately tensioned and secured to thepubic bone (FIG. 28) as will be discussed below. Also contemplated asembodiments of this aspect of the invention are similar connectionsbetween other kinds of medical devices and suture 88 via, for example,arrowhead connector 132 or T connector 134 passing through a cannula 90which has been driven through the pubic bone.

As a further embodiment of the present invention, the securing devices126 of the invention may be used to secure a urethral sling 42 or othermedical device after such a device has been positioned in a tissuecavity that was created transvaginally. For example, a cavity may beopened in the upper vaginal wall 8 by hydrodissection, or by means ofthe spreader 12 of the invention, or by blunt dissection. A medicaldevice such as a urethral sling 42 may then be placed into the cavity,wherein the medical device has one or more ring members 44 capable ofpermitting unidirectional passage of a connector 130 of the securingdevice 126. The appropriate connector 130 is then passed through thecorresponding ring member 44, and the device is secured in place in thetransvaginally created tissue pocket. (See FIG. 23.)

This invention is further characterized by a bone eyelet 150 forsecuring suture 88 to a bone. The bone eyelet 150 consists of a sleeve152 and at least one crosspiece 160. (FIG. 31.) The sleeve 152 has anouter surface 154 that is adapted for inserting into and contacting witha bone, and also has an inner surface 156 such that the sleeve 152 is asubstantially hollow structure with openings at either end. (FIG. 32a.)The crosspiece 160 is attached to the inner surface 156 of the sleeve152, and creates a plurality of channels within the sleeve 152.

Several alternative embodiments of the bone eyelet 150 are contemplatedin the present invention. In one preferred embodiment, the crosspiece160 is a single rod 164. (FIG. 33.) In another preferred embodiment, thecrosspiece 160 is a plane 162. (FIG. 32.) In both of these embodiments,the presence of the single crosspiece 160 produces two channels 168through which a suture 88 may pass. In another embodiment, thecrosspiece 160 is created by crimping or piercing the sleeve 152. Inthis embodiment, the thus-distorted portion of the sleeve 152 becomesthe crosspiece 160, as shown in FIG. 32. In other embodiments, multiplecrosspieces 160 may be present in the sleeve 152, to produce more thantwo channels 168 through which a suture 88 may pass. In anotherembodiment, the sleeve 152 includes a perpendicular flange rim 158. Thisflange rim 158 suspends the sleeve 152 at the surface of the bone andprevents it from sliding into the hole in the bone. (FIGS. 31-33.)

This aspect of the invention provides a method for securing a suture 88to a bone. In this method, a suture 88 is passed through a bone in whicha path for suture 88 has been created, for example, by driving abone-piercing guide 84 according to this invention. Where two ends of asuture 88 both extend past the surface of the bone, each end may beadvanced through one of the channels 168 among the plurality of channels168 provided in the bone eyelet 150. The suture 88 ends may then be tiedtogether and will be prevented from sliding into the bone by the actionof the crosspiece 160 of the bone eyelet 150. (See FIGS. 32, 33.)

Another embodiment of this method includes a step of tensioning thesuture 88 during the tying step to achieve a desired elevation of thestructures to which the suture 88 is attached. For example, this methodmay be employed in connection with a securing device 126 discussed aboveto greatly accelerate and simplify the steps in securing a tissue massor a urethral sling 42 in a tissue cavity. (FIGS. 32, 33.) Accordingly,the bone eyelet 150 may be used in connection with the driver 70 aspectof the this invention, as well as the driver frame assembly 100 aspectof the invention. It may further be adapted for use with other means ofadvancing a suture 88 through a pubic bone.

A further aspect of the present invention provides a bone suturefastener 170 for quick and simplified connection of a suture 88 to abone. (FIGS. 36-38.) The suture fastener 170 consists of a sleeve 172having an opening 174 at each end, and a sleeve plug 178. The sleeve 172is provided with a friction surface 180 for contacting the sleeve plug178 and for preventing disengagement of the plug 178 from the sleeve172. Different embodiments of the bone suture fastener 170 have a sleeve172 that is substantially conical or cylindrical and a sleeve plug 178that is likewise substantially conical or cylindrical. In one embodimentthe friction surface 180 is a plurality of friction flanges 184partially occluding one opening 174 of the suture fastener sleeve 172.(FIGS. 36, 37a.) These flanges 184 flex is one direction to allowinsertion of the sleeve plug 178 into the sleeve 172 and then preventrelease of the sleeve plug 178 from the sleeve 172. In anotherembodiment, the friction surface 180 is threaded 182 and the sleeve 172is substantially cylindrical. (FIG. 38.) The sleeve plug 178 is likewisethreaded 182 and is adapted for frictionally contacting the threads 182of the suture fastener sleeve 172. An additional embodiment, the sleeveplug 178 may have a series of distortable angled rings 179 along itslength, wherein the circumference of the top of each ring 179 is smallerthan the circumference of the bottom of the same ring 179. The suture 88may be tied directly to the sleeve plug 178. In this embodiment, thefriction surface 180 of the sleeve 172 has a rim 183 adapted to allowunidirectional passage of the sleeve plug 178 and to prevent retrogradepassage thereof, resulting in a one-way zipper-lock action. Thisembodiment allows a surgeon to adjust the tension on the suture 88simply by pulling the sleeve plug 178 through the sleeve 172 to thedesired position. (FIG. 37b.) In any of these embodiments, a flange rim186 may extend around the circumference of one end of the sleeve 172 toprevent sinking of the bone suture fastener 170 past the surface of thebone. (FIG. 38.)

This aspect of the invention provides a method for quick and simplesecuring of a suture 88 that has passed through a bone. According to themethod, one or multiple ends of a suture 88 may be passed through thesleeve 172 of the suture fastener 170 and the suture fastener 170 may beadvanced along the suture 88 until it contacts the bone through whichthe suture 88 passes. (FIG. 36.) The sleeve 172 is secured in the bonenear the bone surface either by a friction surface 180 on the outside ofthe sleeve 172, or by a flange rim 186 extending around thecircumference of one end of the sleeve 172. With the sleeve 172 inplace, and the suture 88 passing therethrough, the suture 88 may betensioned to approximately the desired tension and the sleeve plug 178partially inserted into the opening 174 of the sleeve 172 at the surfaceof the bone. Any desired tensioning or release of tension in the suture88 is done prior to final seating of the sleeve plug 178 in the sleeve172 against the friction surface 180. (FIGS. 37a and 38.) When thesleeve plug 178 is appropriately seated against the friction surface180, the suture 88 is secured in place at the surface of the bone, andexcess suture 88 is cut off by the surgeon.

Another embodiment of this aspect of the invention contemplates the useof the bone suture fastener 170 to secure a suture 88 that is connectedto a device or a stitch 92 in a transvaginally created tissue cavity.For example, a tissue cavity is dissected between the urethra and theupper vaginal wall 8 by hydrodissection, blunt instrument dissection, orby the spreader 12 of the invention. Subsequently, a sling 42 or othermedical device may be placed in the cavity, or a suture 88 may be passedthrough a tissue mass to elevate or stabilize the tissue mass (compareFIG. 27a to FIG. 27b and note distance of elevation B, see also FIGS. 9,10, 26). In cases where the suture 88 is passed through the tissue andfollows a path through the pubic bone, the end of the suture 88 thatprotrudes from the pubic bone may be anchored thereto by means of thebone suture fastener 170 of this aspect of the invention. (FIG. 28.)

This method of the invention may be practiced in cooperation withseveral other methods and devices of the present invention. In anyaspect of the invention in which a suture 88 is passed through a bone,the suture 88 may be advantageously secured to the bone in this manner.Thus, the quick connect bone suture fastening may be used incoordination with the quick connect securing devices 126 used to connecta sling 42 or other internally placed medical device with a suture 88.They also may be used to secure the ends of a suture 88 that has beenpassed through a tissue mass by stitching 92. They also may be used inconnection with the bone-piercing guide driver 70 or with the driverframe assembly 100 of the invention.

Accordingly, the several aspects of the present invention cooperate toachieve the desired effect of providing a variety of surgical optionsfor and solutions to problems associated with stress urinaryincontinence and related dysfunctions or deformations of the urethral orpelvic floor. Also contemplated within the overall scope of the presentinvention are other applications for securing a soft target tissue to arelatively fixed reference tissue, such as the pubic bone. It isunderstood that the examples of embodiments and methods provided hereinare merely representative of the invention, and are not taken to limitthe invention beyond the express limitations of the following claims.

What is claimed is:
 1. A dilator for creating a cavity, comprising:aninsertion spreader comprising a first elongate semi-cylindrical spreaderguide and a second elongated semi-cylindrical spreader guide, said firstand second guides each having a distal end and a proximal end, saidfirst and second guides being sharpened at said distal ends, said firstguide being parallel to said second guide, said guides of said insertionspreader being movable between a closed position and an open position; afirst and a second handle, each of said handles having a first end and asecond end, wherein said first end of said first handle is attached tosaid first guide, said first end of said second handle is attached tosaid second guide, wherein the longitudinal axis of said first andsecond handles is substantially perpendicular to the longitudinal axisof said first and second guides, respectively, and said second end ofeach of said handles is adapted to allow a person to grasp andmanipulate said dilator; and a pivot intermediate said first end andsaid second end of each of said handles, said handles being movablyconnected at said pivot, whereby movement of said handles about saidpivot causes a displacement of said guides to move said guides betweensaid closed and said open positions.
 2. The dilator of claim 1 furthercomprising a ratcheting lock for maintaining said insertion spreader ina fixed position.
 3. The dilator of claim 1, wherein said second ends ofsaid handles comprise finger loops for grasping and manipulating saiddilator.
 4. The dilator of claim 1, wherein said first and secondspreader guides generally form a cylinder when in placed in the closedposition.
 5. The dilator of claim 1, wherein said the separation of saidfirst and second spreader guides in the open position is approximately2.5 to 4 cm.